Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.

Friday, October 01, 2010

Cart before the horse, again: IOM to study HIT patient safety for ONC; should HITECH be repealed?

In my July 2010 post "Meaningful Use Final Rule" I pointed out the cart-before-the-horse problem of creating "meaningful use" rules for health IT before usability issues were resolved:

From the HIMSS EHR Usability Task Force, June 2009:

Electronic medical record (EMR) adoption rates have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available. Achieving the healthcare reform goals of broad EMR adoption and “meaningful use” will require that efficiency and usability be effectively addressed at a fundamental level.

These "usability" problems require long term solutions. There are no quick fix, plug and play solutions. Years of research are needed, and years of system migrations as well for existing installations.

Yet we now have an HHS Final Rule on "meaningful use" regarding experimental, unregulated medical devices the industry itself admits have major usability problems, along with a growing body of literature on therisks entailed.

The Institute of Medicine (IOM) announced it will conduct a year-long study for the Office of the National Coordinator for Health IT to identify best policies and practices for improving healthcare safety when using electronic health records.

The IOM, an arm of the National Academy of Sciences, will examine prevention of health IT-related errors, rapid reporting of patient safety concerns[To whom? The vendor, as now, so they can sit on the problems until it suits them to fix it? In the face of contractual gag clauses, I'm not sure where else such reports can go - ed.] and methods to promote safety-enhancing features of electronic health records (EHRs), said Dr. David Blumenthal, the national health IT coordinator.

The IOM will also make recommendations about the potential effects of government policies and private sector efforts to make the most of patient safety and avoid medical errors through health IT.

[In reading the hype right up to the ONC Director Blumenthaland the POTUS,one would get the impression that medical error-prevention was an inherent, deterministic characteristic of this 100% beneficent technology, so much so that simply putting it in will revolutionize medicine. Now, we all of a sudden need to study its safety? - ed].

... “This study will draw on IOM’s depth of knowledge in this area to help all of us ensure that HIT reaches the goals we are seeking for patient safety improvement,” Blumenthal said.

Earlier this year, the Health IT Policy Committee, a federal advisory group, conducted hearings about patient safety and EHRs. It recommended creating a national database to which healthcare providers can report patient data errors and unsafe conditions they encounter using EHRs.

[To reiterate, there is a major problem with this proposal: "providers" cannot do this with contractual gag clauses in effect. It also seems such databases belong at the state level, since the control of medicine traditionally resides in the states, but these days the Federal government seems to know no bounds - ed.]

The committee also urged the establishment of a patient safety organization to analyze the reports and share information from the database to make healthcare a learning system.

So, in the midst of a National Program for Health IT in the United States (NPfIT in the U.S.), with tens of billions of dollars earmarked for health IT already (money we don't really have, but it can be printed quickly, or borrowed from China) the IOM is going to study health IT safety, prevention of health IT-related errors, etc. ... only now?

Perhaps these studies should have been initiated, say, ten years ago, or at least before the beneficence of health IT and its capacity to revolutionize medicine was openly promoted by the past and current Administrations (the current one going so far as to institutionalize penalties for non adopters)?

A move like this suggests someone's blown the whistle on the purveyors of the NPfIT in the U.S. They are now attempting to cover their tracks regarding this glaring deficiency (unknown risk) in an already-initiated, extremely expensive national program based on equivocal studies and literature, an increasing amount of which is now refuting the grandiose claims made about health IT. The purveyors would seem to have a figurative gun at their heads causing them to ask the IOM for assistance at this rather late date in the scheme of things (could that gun be named Grassley?)

A tidbit of common sense regarding IT, all too lacking in today's national leadership:

You should not need year-long IOM studies to study the safety of supposedly safe devices already slated for national rollout.

Finally, the sudden interest in health IT safety suggests the HITECH act on health IT with its timelines and penalties, 'smuggled' in under the auspices of the ARRA, is premature. HITECH's timelines should be delayed delayed until this technology and its safety is truly understood (or it should be repealed entirely and redone in a non-cavalier fashion).

-- SS

10/2/10 addendum:

I recall that we already have the 2009 National Research Council HIT study. It reported that HIT in its present form does not support physician cognitive needs and that our approaches to HIT are "insufficient" to achieve stated goals...

The U.S. National Research Council’s "Current Approaches to U.S. Health Care Information Technology are Insufficient" is here.A full report on an investigation of healthcare IT lack of progress ishere (PDF).

From the NRC/NAS/IOM sites:

"The National Research Council (NRC) functions under the auspices of the National Academy of Sciences (NAS), the National Academy of Engineering (NAE), and the Institute of Medicine (IOM)." ... "The IOM is the health arm of the NAS."

The National Research Council report on HIT was basically buried. HITECH happened anyway.

ONC seems to now be going back to the same source(s), presumably for either a glowing report, or a report that it can safely ignore.

Finally:

That HIT effectiveness issues, safety issues, admittedly poor usability but "meaningful use" criteria crafted anyway, lack of clinician cognitive support requiring years of multidisciplinary research to correct, etc. - have had no inhibitory effect on grandiose, autocratic and highly expensive plans for national HIT also suggest political agendas far beyond "improving patient care."

There are deaths, injuries, and near misses happening every day at the highly wired hospitals, especially the hospitals for pediatrics. The events are not being reported, and when pressured to do so, the damage control experts of hospital and vendor fend off the truth. Safety committee meetings consist of figuring out why something should not be reported. I am not pretty sure...I am certain that the Seattle Times covered the covered up errors within the past 2 weeks.

There are deaths, injuries, and near misses happening every day at the highly wired hospitals, especially the hospitals for pediatrics. The events are not being reported, and when pressured to do so, the damage control experts of hospital and vendor fend off the truth. Safety committee meetings consist of figuring out why something should not be reported. I am not pretty sure...I am certain that the Seattle Times covered the covered up errors within the past 2 weeks.

I hate to have to point this out, because it should be blatantly obvious, but nothing you posted here is evidence of "gag clauses". You need to find someone who actually has witnessed a "gag clause". HISTalk couldn't even find an anonymous source. It seems pretty obvious that they don't exist.

I'm pretty sure the claims about "gag clauses" were exposed as lies over at HISTalk. There are no "gag clauses".

"Exposed as lies at HisTALK?"

Koppel and Kreda were just making it all up, I imagine.

My observations on the lack of scientific research understanding among health IT workers was part of what led me to formulate the question a decade ago: "who are these people, and exactly what credentials and expertise do they have that entitles them to work in healthcare settings and interfere in clinical affairs?

I'm sorry to say I still have not had a satisfactory answer.

In my own teaching, my grad students must read essays on critical thinking, logical fallacy, and must learn how to perform a comprehensive literature survey of the peer reviewed and periodical literature.

It is clear that anyone speaking ill of HIT, at least in my town, had their career ruined. So if there were such agreements, no one would reveal them. If there aren't such agreements, it is as if they existed since many wouldn't dare to speak out.

There simply is no cover for whistleblowers in Healthcare, doubly so in HIT.

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